BEUDAMED
    FDA Recall Terminated

    BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136

    Recall: Z-1451-06 · Initiated June 27, 2006

    Recall

    Recall Number
    Z-1451-06
    Event Number
    36048
    Firm
    Hardy Media Inc Dba Hardy Diag
    FEI Number
    2022807
    Product Code
    JSO
    Status
    Terminated
    Root Cause
    Other
    Initiated
    June 27, 2006
    Posted
    August 29, 2006
    Terminated
    June 14, 2011
    Address
    1430 W Mccoy Ln, Santa Maria, CA, 93455-1005

    Description

    BHI Agar with Vancomycin, for in vitro diagnostic use. Catalog # G14, Lot# 06136

    Reason

    This recall is being conducted due to the performance failure nearing the end of the product shelf life.

    Action

    Customers were first notified by phone on 6/28/06, then all customers were faxed and mailed a signed recall letter via first class mail.

    Distribution

    Nationwide in AZ, CA, IA, ID, MI, MT, NC, & WY. Plus: Puerto Rico

    Quantity

    860 plates